Director, Regulatory Site CMC

Role Summary

The Director Regulatory Site CMC ensures efficient and compliant management of regulatory change control and post-approval activities at the site level. Supporting diverse modalities—including small molecules, biologics, and external manufacturing sites—the role employs an agile approach to drive standardization, scalability, and sustainability. This position leverages ICH Q12 principles to streamline post-approval change management and explores automation to enhance predictability and repeatability in regulatory processes. The role requires strong practical experience with global HA requirements, beyond EU/US, and the ability to communicate regulatory strategy to drug development, registration, and post-market support teams. Location: Boston, MA.

Responsibilities

• Lead site-specific post-approval change management activities, including record evaluations and regulatory submissions (considering possible strategic bundling of changes), ensuring compliance with global requirements.
• Apply science- and risk-based approaches, guided by ICH Q12 principles, to assess and implement post-approval changes.
• Drive the adoption of standardized processes and tools to enhance predictability, scalability, and sustainability in site-based regulatory activities.
• Explore and implement automation technologies to increase efficiency and ensure repeatability in change control and regulatory submissions.
• Provide centralized regulatory support for multiple manufacturing sites, including external partners, covering small molecules and biologics.
• Collaborate with external manufacturing sites and suppliers to align change control processes with global regulatory expectations.
• Ensure site compliance with global regulatory requirements by evaluating and prioritizing changes based on risk and scientific rationale.
• Facilitate alignment between site teams and global Regulatory CMC on post-approval strategies and activities and represent global Regulatory CMC in cross-functional Change Review meetings.
• Implement streamlined workflows for regulatory change control, leveraging digital tools and automation to minimize delays and maximize impact.
• Promote sustainable practices and scalability in site-level regulatory operations.

Qualifications

• BS/BA Degree in a Scientific Discipline; Advanced Degree (M.S., Ph.D., etc.) preferred.
• 10+ years of overall biopharmaceutical/device industry experience with 8+ years of direct Regulatory CMC or Regulatory Device experience required (including leading a major variation/amendment, supporting an initial IND/IMPD preparation, or supporting an initial NDA/BLA).
• Strong practical experience with global HA requirements, beyond EU/US.
• Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and post-market support.
• Proven ability to understand and communicate regulatory strategy to drug development, registration, and post-market support teams.
• Experience analyzing issues with attention to detail and assessing alternative approaches.
• Proven ability to develop global regulatory strategy recommendations based on precedents, regulatory intelligence, and applicable regulations and guidelines.
• Ability to operate with minimal oversight, exercise good judgment, and escalate issues when necessary.
• Demonstrated leadership, problem-solving ability, flexibility, and teamwork; promotes an inclusive culture and effectively applies prioritization frameworks.
• Excellent written and oral communication skills; strong leadership, collaboration, negotiation, problem-solving, and interpersonal skills.

Education

• BS/BA in a scientific discipline; advanced degree preferred.

Skills

• Regulatory strategy development and communication
• Regulatory change control and post-approval management
• ICH Q12 principles and risk-based decision making
• Automation and digital tool utilization for regulatory processes
• Cross-functional collaboration and stakeholder management